Flávio D Fuchs , 1 , Sandra C Fuchs 1 , Leila B Moreira 1 , Miguel Gus 1 , Antônio C Nóbrega 2 , Carlos E Poli-de-Figueiredo 3 , Décio Mion 4 , Luiz Bortolotto 5 , Fernanda Consolim-Colombo 5 , Fernando Nobre 6 , Eduardo Barbosa Coelho 6 , José F Vilela-Martin 7 , Heitor Moreno Jr 8 , Evandro José Cesarino 9 , Roberto Franco 10 , Andréa Araujo Brandão 11 , Marcos R de Sousa 12 , Antônio Luiz Pinho Ribeiro 12 , Paulo Cesar Jardim 13 , Abrahão Afiune Neto 14 , Luiz César N Scala 15 , Marco Mota 16 , Hilton Chaves 17 , João Guilherme Alves 18 , Dario C Sobral Filho 19 , Ricardo Pereira e Silva 20 , José A Figueiredo Neto 21 , Maria Cláudia Irigoyen 22 , Iran Castro 22 , André Avelino Steffens 23 , Rosane Schlatter 1 , Renato Bandeira de Mello 1 , Francisca Mosele 1 , Flávia Ghizzoni 1 , Otávio Berwanger 24
24 February 2011
Cardiovascular disease is the leading cause of death in Brazil, and hypertension is its major risk factor. The benefit of its drug treatment to prevent major cardiovascular events was consistently demonstrated. Angiotensin-receptor blockers (ARB) have been the preferential drugs in the management of hypertension worldwide, despite the absence of any consistent evidence of advantage over older agents, and the concern that they may be associated with lower renal protection and risk for cancer. Diuretics are as efficacious as other agents, are well tolerated, have longer duration of action and low cost, but have been scarcely compared with ARBs. A study comparing diuretic and ARB is therefore warranted.
This is a randomized, double-blind, clinical trial, comparing the association of chlorthalidone and amiloride with losartan as first drug option in patients aged 30 to 70 years, with stage I hypertension. The primary outcomes will be variation of blood pressure by time, adverse events and development or worsening of microalbuminuria and of left ventricular hypertrophy in the EKG. The secondary outcomes will be fatal or non-fatal cardiovascular events: myocardial infarction, stroke, heart failure, evidence of new subclinical atherosclerosis and sudden death. The study will last 18 months. The sample size will be of 1200 participants for group in order to confer enough power to test for all primary outcomes. The project was approved by the Ethics committee of each participating institution.
The putative pleiotropic effects of ARB agents, particularly renal protection, have been disputed, and they have been scarcely compared with diuretics in large clinical trials, despite that they have been at least as efficacious as newer agents in managing hypertension. Even if the null hypothesis is not rejected, the information will be useful for health care policy to treat hypertension in Brazil.